Kornimate/medical-research-clean huggingface dataset:
instrument utility for suspected asthma (0000-042)(completed)

Conditions: Asthma

Summary: this research study was designed to help improve the diagnosis and treatment of asthma in young children. an interventional strategy using a scoring system based on risk factors and symptoms/episodes was tested to determine its ability to identify children likely to benefit from induction of asthma controller therapy at an early age. the score was derived through completion of a survey instrument referred to as the asthma risk questionnaire (arq). the utility of the arq along with the health care utilization and use of controller therapy for respiratory illnesses within one year were examined.


Eligibility criteria:
inclusion criteria: * children less than or equal to 6 years of age who had at least 1 year prior episode of wheezing exclusion criteria: * children with other systemic or chronic respiratory disease and children who used an asthma controller medication with the 6 weeks prior to enrollment
blood proteins in predicting treatment benefit in patients with recurrent and/or metastatic head and neck squamous cell cancer

Conditions: Head and Neck Cancer

Summary: rationale: studying samples of blood in the laboratory may help doctors learn more about cancer. it may also help doctors predict how well patients will respond to treatment. purpose: this research study is looking at proteins in blood samples to predict treatment benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.

objectives: * to identify head and neck squamous cell cancer patients who will benefit from treatment with the egfr inhibitors (i.e., erlotinib hydrochloride, gefitinib, and cetuximab) and vegf inhibitor (i.e., bevacizumab), based on predictive proteomic profiles in patient blood samples. outline: this is a multicenter study. blood samples are analyzed for proteomic profile to determine good and bad prognoses in patients treated with or without egfr inhibitors and/or a vegf inhibitor.

Eligibility criteria:
disease characteristics: * diagnosis of squamous cell head and neck cancer * recurrent and/or metastatic disease * meets 1 of the following criteria: * previously treated with egfr inhibitors and/or vegf inhibitor on 1 of the following clinical trials, and has available blood samples: * a phase i/ii study of bevacizumab (rhu mab vegf) in combination with osi-774 for patients with recurrent or metastatic cancer of the head and neck * a phase ii study of 250-mg zd1839 monotherapy in recurrent or metastatic or both recurrent and metastatic squamous cell carcinoma of the head and neck * previously treated with cetuximab and has blood samples available from protocol vu-vicc-hn-0356 * previously treated with conventional chemotherapy and has blood samples available from protocol vu-vicc-hn-0356 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage iv squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage iv squamous cell carcinoma of the paranasal sinus and nasal cavity salivary gland squamous cell carcinoma stage iv salivary gland cancer recurrent salivary gland cancer
lipid balance in adult sickle cell patients

Conditions: Sickle Cell Disease; Dyslipidemia; Complication

Summary: this study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (sca) and sc sickle cell patients living in the french west indies and followed by scd reference and competence centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (scd) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (voc) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- genetic primary modulators of scd complications, 5- insulin resistance (homa), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of hdl in sub-groups of scd population.

* cohorts of sickle cell disease patients including sickle cell anemia (sca) and sc sickle cell patients living in guadeloupe and martinique and followed by the sickle cell disease (scd) reference and competence centers of french west indies. * lipid profile includes total cholesterol, hdl-cholesterol, non-hdl-cholesterol, ldl-cholesterol and triglycerides, apolipoprotein a-i and b. medical histories and prospective collection of scd complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, voc, priapism, pulmonary arterial hypertension (pah) and pah sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy. * objective 4: to describe genetic primary modulators of scd complications: fetal hemoglobin, alpha-thalassemia, haplotypes of beta s gene. * objective 5 will be performed in the entire cohort at inclusion and during prospective complications (voc, priapism). * objective 6 will be performed in a sub-group of 90 individuals (n=15 with voc and n= 15 without voc, n=15 with priapism and n=15 without priapism, n= 15 with pulmonary arterial hypertension syndrome (pah sd) and n=15 without pah sd), as well as in a subgroup of n = 15 patients prospectively experiencing voc and n = 15 patients prospectively experiencing priapism. a collection of plasma is performed to fulfill objective 6, as well as a collection of blood cells for later researches.

Eligibility criteria:
inclusion criteria: * aged from 18 years and over * be affected with sickle cell anemia or sc sickle cell * living in french caribbean islands of guadeloupe or martinique and followed by physicians issued from a french west indies sickle cell reference or competence center * at steady state in the last month (without acute complication) * to have given a written consent after information on the study. exclusion criteria: * other hemoglobinopathies than sickle cell disease * pregnancy or lactation * patient under judicial protection or without freedom * patient not affiliated with a social security system * patient hospitalized for transfusion or bleeding in the last 3 months

Keywords: sickle cell disease lipids vasoocclusive crisis priapism pulmonary arterial hypertension
study to assess efficacy, safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of obeticholic acid (oca) compared to placebo in pediatric participants with biliary atresia, post-hepatoportoenterostomy

Conditions: Biliary Atresia

Summary: this study will evaluate the efficacy, safety and tolerability, as well as pk/pd of oca in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (hpe, also known as a kasai portoenterostomy). the double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.


Eligibility criteria:
inclusion criteria: * male or female pediatric participants from birth to \<18 years old. note: participants aged \<2 years old will not be enrolled until after review of safety data during the planned interim analysis and agreement from the data safety monitoring board (dsmb) that there is sufficient safety data to enroll this age group. * diagnosis of non-syndromic biliary atresia. * demonstrated successful hpe as defined by total bilirubin \<2 milligrams per deciliter (mg/dl) (34.2 micromoles per liter \[μmol/l\]) at least 3 months post-hpe procedure. exclusion criteria: * prior liver transplant or active status on transplant list. * participants diagnosed with biliary atresia splenic malformation (basm). * conjugated (direct) bilirubin ≥ upper limit of normal (uln) of site-specific reference range. if conjugated bilirubin is not available: total bilirubin ≥2 mg/dl (34.2 mol/l). * platelets \<120,000/μl * international normalized ratio (inr) ≥1.5. * current or history of complications of decompensated chronic liver disease including: 1. gastroesophageal varices and/or variceal bleeding 2. clinically evident ascites related to portal hypertension 3. hepatic encephalopathy 4. prior placement of portosystemic shunt 5. hepatopulmonary syndrome or portopulmonary hypertension 6. hepatorenal syndrome 7. any evidence of portal hypertension based on imaging (e.g., cavernous transformation of portal vein, abdominal varices, etc.) 8. hepatocellular carcinoma 9. childs-pugh b or c * height and weight z-score \<-2 per site-specific reference ranges. * acholic (pale) stools. * aspartate aminotransferase (ast) \>4x uln. * alanine aminotransferase \>4x uln * ggt \>500 units per liter (u/l) * on anticoagulation therapy * albumin \<3.5 grams per deciliter (g/dl). * inability to swallow tablets (i.e., tablet or mini-tablet formulations).

Keywords: biliary atresia placebo-controlled pharmacokinetics pharmacodynamics obeticholic acid efficacy post-hepatoportoenterostomy
stress and tooth structure loss in dental students.

Conditions: Tooth Wear

Summary: the study is designed as a pilot study. the primary objective of the current study is to collect data on the expression and progression of tooth structure loss in dental students under stressful conditions and different dietary habits using intraoral scanners (ios). stress levels will be evaluated using percived stress scale (pss-10). eating habits will be queried using reflux and dietary questionnaires. the data obtained will later be used in the case-control design of a multicenter study on the same topic. conducting the pilot study will allow for a critical evaluation of the study's design, participant retention rate, and recruitment process.

the first scan (baseline: t0) is performed during the dental prosthetics i course, at the beginning of the 8th semester. follow-up scans t1 and t2 are performed at the beginning of the 10th semester and after completion of the state examination. the scans are performed by a study doctor or doctoral student using a digital intraoral scanner (trios, 3 shape, denmark). accompanying the scanning process, study participants will be asked to complete a questionnaire regarding stress levels (pss) and dietary habits. a medical history and dental findings are also collected. each scan will take no longer than 10 minutes. the entire examination will take no longer than 45 minutes. the t0 and t1, t2 scans will be overlaid with evaluation software and compared in terms of tooth wear.

Eligibility criteria:
inclusion criteria: * at the time of the baseline examination of the study the participants must be dental students and participate in the dental prosthetics course i in the summer semester 2023, at the dental school of medical faculty carl gustav carus at the technical university of dresden * presence of study teeth (at least one antagonist pair of first molars (16/46 or 26/36). * complete dentition, if necessary, dentition with complete gap closure up to the first molar in the maxilla and mandible * presence of a canine guidence * written informed consent of the participating persons exclusion criteria: * age \ 40 * study teeth restored with dentures * extensive restorations over 1/3 of the occlusal surface on the study teeth * removable dentures * ongoing orthodontic treatment * existing pregnancy/lactation * addiction or other medical conditions that do not allow the subject to understand the nature and scope and possible consequences of the clinical study * indications that the participant is unlikely to comply with the protocol.
a precision medicine approach using gene silencing to treat a chronic liver disease called metabolic dysfunction-associated steatohepatitis (mash) in adult participants at increased genetic risk for this condition

Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)

Summary: this study is researching an investigational drug, aln-hsd called "study drug". this study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (mash). mash is a form of metabolic dysfunction-associated steatotic liver disease (masld). mash occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). mash can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). the aim of the study is to see the effect of the study drug on lessening liver scarring side effects related to mash. the study is looking at several other research questions, including: * how aln-hsd works to improve liver function and lessen mash-related inflammation in the liver * what side effects may happen from receiving the study drug * how much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times * better understanding of the study drug and mash


Eligibility criteria:
key inclusion criteria: 1. adult male or female ≥18 years (or country's legal age of adulthood) 2. a diagnosis of mash with fibrosis (f) stage 2 or 3, according to the nash-clinical research network (crn) 3. nas score ≥3, as defined in the protocol 4. meets genotype criteria for study enrollment, as defined in the protocol 5. has protocol defined fibroscan®-ast (fast) score at screening or within approximately 12 weeks of screening key exclusion criteria: 1. evidence of other forms of known chronic liver disease, as defined in the protocol 2. known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol 3. history of type 1 diabetes 4. bariatric surgery within approximately 5 years prior to or planned during the study period 5. prior exposure to any investigational drug targeting hsd17b13 or patatin-like phospholipase domain containing 3 (pnpla3) (eg, aln-hsd, aro-hsd, aln-pnp, azd2693) note: other protocol-defined inclusion/exclusion criteria apply

Keywords: metabolic dysfunction-associated steatotic liver disease (masld) histologically confirmed mash genetic risk alleles for mash at the hsd17b13 locus non-alcoholic steatohepatitis (nash)
perioperative hypothermia and myocardial injury after non-cardiac surgery

Conditions: Perioperative Care; Surgery--Complications; Hypothermia; Anesthesia; Myocardial Injury

Summary: we propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. half of the participants will be randomly assigned to routine care (core temperature ≈35.5°c), while the other half will receive aggressive warming (\>37°c core temperature) in a multi-center trial.

hypothermia increases sympathetic activation, promotes tachycardia, and causes hypertension - all of which may increase the risk of myocardial injury. moderate perioperative hypothermia is now uncommon, but mild hyperthermia (≈35.5°c) remains common. whether aggressive warming to a truly normothermic level (≈37°c) improves outcomes remains unknown.

Eligibility criteria:
inclusion criteria: * scheduled for major noncardiac surgery expected to last 2-6 hours; * having general anesthesia; * expected to require at least overnight hospitalization; * expected to have \>50% of the anterior skin surface available for warming; * have at least one of the following risk factors: a. age over 65 years; b. history of peripheral vascular surgery; c. history of coronary artery disease; d. history of stroke or transient ischemic attack; e. serum creatinine \>175 µmal/l (\>2.0 mg/dl); f. diabetes requiring medication; e. hypertension requiring medication; g. current smoking. exclusion criteria: * have a clinically important coagulopathy in the judgement of the attending anesthesiologist; * are septic (clinical diagnosis by the attending anesthesiologist); * body mass index exceeding 30 kg/m2; * end-stage renal disease requiring dialysis; * surgeon believes patient to be at particular infection risk.

Keywords: hypothermia intraoperative warming non-cardiac surgery myocardial injury
the life insight application study (lisa)

Conditions: Quality of Life

Summary: background: it is widely recognised that spiritual care plays an important role in physical and psychosocial well-being of cancer patients but there is little evidence based research on the effects of spiritual care. the investigators will conduct the first randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. the aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients. design: based on the findings of the investigators previous research, the investigators have developed a brief interview model that allows spiritual counselors to explore, explicate and discuss life events and ultimate life goals with cancer patients. to support the interview, the investigators created an e-application for a pc or a tablet. to examine whether this assisted reflection improves quality of life the investigators will conduct a randomized trial. patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. the intervention group will have two consultations with a spiritual counselor using the interview scheme supported by the e-application. the control group will receive care as usual. at baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption. discussion: having insight into one's ultimate life goals may help to cope with a life event such as cancer. this is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients' quality of life and spiritual well being. the intervention is brief and based on concepts and skills that spiritual counselors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age with advanced cancer not amenable to curative treatment. * life expectancy ≥ 6 months. exclusion criteria: * karnofsky performance score \< 60. * insufficient command of the dutch language to fill out dutch questionnaires. * current psychiatric disease
postoperative relapses in ms patients

Conditions: Multiple Sclerosis Relapse; Surgery; Anesthesia

Summary: the aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with ms who received general or regional anesthesia


Eligibility criteria:
inclusion criteria: diagnosed ms - exclusion criteria: refuse to participate -
effect of diaphragmatic strengthening exercises on diaphragm muscle function in patients with post covid-19 syndrome.

Conditions: Corona Virus Infection

Summary: the aim of this work is to study the incidence of diaphragmatic dysfunction after covid 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function.


Eligibility criteria:
inclusion criteria: * male and female above 18 years old * history of probable or confirmed sars-cov-2 infection 3 months from the onset of symptoms or at least 2 months from the end of symptoms . exclusion criteria: * subjects under 18. * patients known to have chronic lung disease . * patients known to have neuromuscular disorder. * patients known to have diaphragmatic hernia. * patients known to have malignancy. * patients with clinical evidence of phrenic nerve injury. * patients with recent abdominal or thoracic surgery, * patients with history of traumatic lesion possibly affecting diaphragm. * subjects with severe malnutrition. * patients with bmi more than 30

Keywords: diaphragmatic function post covid exercises
a clinical study to evaluate efficacy and safety of hlx10 combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy

Conditions: Cervical Cancer

Summary: this is a single-arm, open-label, multicentre, phase ii clinical study.subjects can only enter this study after they meet the inclusion and exclusion criteria.all enrolled patients will receive the treatment with hlx10 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. albumin-bound paclitaxel may be used for up to 6 cycles and hlx10 for up to 2 years.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate and have signed the informed consent form (icf); 2. aged ≥ 18 years and ≤ 75 years at the time of signing the icf 3. patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma). 4. patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. first-line chemotherapy includes any of the following: 1. platinum-based drugs + taxanes; 2. platinum-based drugs + topotecan; 3. taxanes + topotecan. 5. the radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the recist v1.1(irrc). 6. patients whose tumour specimens are tested positive for pd-l1 expression (cps ≥ 1). 7. an ecog score of 0 or 1. 8. conforming to laboratory measurements; exclusion criteria: 1. patients who have previously received albumin-bound paclitaxel. 2. patients with other active malignancies within 5 years or at the same time. 3. patients who are preparing for or have received an organ or bone marrow transplant. 4. presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 5. central nervous system (cns) or leptomeningeal metastases confirmed by imaging or pathological examination. 6. class iii to iv cardiac insufficiency according to nyha classification or an lvef (left ventricular ejection fraction) \< 50% by cardiac colour doppler. 8.with human immunodeficiency virus (hiv) infection. 9.with active pulmonary tuberculosis. 10.have received any t-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic t lymphocyte-associated antigen-4 (ctla-4) inhibitors, pd-1 inhibitors, pd-l1/2 inhibitors, or other agents that target t cells.